Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05148052
Collaborator
Asan Medical Center (Other), National Traffic Injury Rehabilitation Hospital (Other), Korea Workers' Compensation and Welfare Service Incheon Hospital (Other)
36
4
2
19
9
0.5

Study Details

Study Description

Brief Summary

The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual reality exergames
  • Behavioral: Conventional occupational therapy
N/A

Detailed Description

This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Thirty-six chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Conventional therapy first

Group receiving conventional occupational therapy first and then virtual reality exergames.

Device: Virtual reality exergames
Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

Behavioral: Conventional occupational therapy
Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

Experimental: Virtual reality first

Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.

Device: Virtual reality exergames
Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

Behavioral: Conventional occupational therapy
Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

Outcome Measures

Primary Outcome Measures

  1. Action Research Arm Test [Within 2 days after the end of each intervention]

    As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.

Secondary Outcome Measures

  1. Box and Block test [Within 2 days after the end of each intervention]

    an upper extremity function evaluation tool

  2. Fugl-Meyer (FM) Assessment [Within 2 days after the end of each intervention]

    an upper extremity function evaluation tool

  3. Modified Barthel Index [Within 2 days after the end of each intervention]

    an evaluation tool for assessing activities of daily living

  4. Grip strength [Within 2 days after the end of each intervention]

    Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter

  5. Beck Depression Inventory (BDI) [Within 2 days after the end of each intervention]

    an evaluation tool for severity of depression in normal and psychiatric populations

  6. Simulator Sickness Questionnaire [Day 1 and Day 12 of virtual reality exergames intervention]

    an evaluation tool for assessing the subjective severity of simulator sickness symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke

  • Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)

  • Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively

  • Patients who can stably maintain a sitting position

  • Patients who voluntarily agreed to participate in the study

Exclusion Criteria:
  • Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)

  • Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.

  • Patients with a history of severe vertigo or epilepsy

  • Patients with medical reasons such as medical conditions that make it difficult to participate in research

  • Patients who may be pregnant or who are pregnant or lactating

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea Workers' Compensation & Welfare Service Incheon Hospital Incheon Korea, Republic of 21417
2 Seoul National University Hospital Seoul Korea, Republic of 03080
3 Asan Medical Center Seoul Korea, Republic of 05505
4 Korea Worker's Compensation and Welfare Service Incheon Hospital Seoul Korea, Republic of 12564

Sponsors and Collaborators

  • Seoul National University Hospital
  • Asan Medical Center
  • National Traffic Injury Rehabilitation Hospital
  • Korea Workers' Compensation and Welfare Service Incheon Hospital

Investigators

  • Principal Investigator: Han Gil Seo, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Han Gil Seo, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05148052
Other Study ID Numbers:
  • Stroke-VR-U/Ex
First Posted:
Dec 8, 2021
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Han Gil Seo, Associate Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022